Clause 14 - Certification and Examination

Clause 14.1 Certification

An acceptable way to comply with Clause 14.1 is for the final proof to be certified but this is not obligatory provided that that which is certified is in its final form to which no subsequent amendments will be made. Companies may use validated electronic signatures for certifying material. Paper or electronic copies of certificates and the final form of material etc must be preserved in order to comply with Clause 14.6.

When certifying material where the final form is to be printed companies can certify the final electronic version of the item to which no subsequent amendments will be made. When such material is printed the company must ensure that the printed material cannot be used until an appropriately qualified person has checked and signed the item in its final form. In such circumstances the material will have two certificates and both must be preserved.

All promotional material must be certified in this way including audio and audio-visual material, promotional material on databases, interactive data systems and the Internet and relevant representatives’ briefing materials. Promotional aids must also be certified. Although not strictly promotional material they are used for a promotional purpose.

Account should be taken of the fact that a non-promotional item can be used for a promotional purpose and therefore come within the scope of the Code.

In certifying audio and audio-visual material and promotional material on databases, interactive systems and the Internet, companies must ensure that a written transcript of the material is certified including reproductions of any graphs, tables and the like that appear in it. In the event of a complaint, a copy of the written material will be requested. Alternatively, companies may certify material on interactive systems by means of producing an electronic copy, for example on a CD Rom or data stick, if the electronic copy is write protected and unable to be changed.

The guidelines on company procedures relating to the Code (on page 54 of the printed Code) give further information on certification.

See also the supplementary information to Clause 3 on promotion at international conferences regarding the certification of such material.

When certifying dynamic content for websites, care must be taken to ensure the dynamic content meets the requirements of the Code as a standalone item. As the final form of digital  material might not be static, consideration needs to be given to the context in which it appears but each possible combination does not need to be certified.

In deciding whether a person can be a nominated signatory, account should be taken of product knowledge, relevant experience both within and outwith the industry, length of service and seniority. In addition signatories must have an up-to-date, detailed knowledge of the Code.

In a joint venture in which a third party provides a service on behalf of a number of pharmaceutical companies, the pharmaceutical companies involved are responsible for any activity carried out by that third party on their behalf.

It follows therefore that the pharmaceutical companies involved should be aware of all aspects of the service carried out on their behalf and take this into account when certifying the material or activity involved. Similarly if two or more pharmaceutical companies organise a joint meeting each company should ensure that the arrangements for the meeting are acceptable.

Under co-promotion arrangements or other arrangements where companies work together, such as joint working projects, the companies concerned can agree to have only one final signatory to certify on behalf of all the companies. This must all be agreed beforehand and the Medicines and Healthcare products Regulatory Agency and the Prescription Medicines Code of Practice Authority must be informed in advance who the signatories will be. In the event of a complaint about material certified in this way each company involved in the project/activity would be responsible under the Code.

UK Companies have responsibilities under the Code for meetings which they organise and when UK delegates and/or UK speakers are invited or supported to go to meetings outside the UK. Clauses 23 and 24 in relation to disclosure of transfers of value will also need to be followed.

When certifying arrangements for meetings which involve travel outside the UK all the relevant documents and arrangements must be considered including the programme, the venue, the reasons for using that venue, the intended audience, the anticipated cost and the nature of the hospitality and the like.

If the company’s only involvement is to support a speaker to present at the meeting and there is no pharmaceutical company involvement with the meeting at all, for example a learned society meeting, then neither certification nor  examination is required.

When a pharmaceutical company based outside the UK arranges via a UK company for a UK speaker to present at a meeting to be held outside the UK, then that speaker’s presentation materials do not need to be certified or examined by the UK provided there are no UK delegates and the UK company has no role whatsoever in relation to the meeting or the presentation. In such circumstances the meeting arrangements, in as much as they apply to the UK speaker, will not have to be certified or examined.

In deciding whether a person is appropriately qualified to certify meetings involving travel outside the UK, when this is done by someone other than registered medical practitioner or a UK registered pharmacist, account should be taken of relevant experience both within and outwith the industry, length of service and seniority. In addition such a person must have an up-to-date and detailed knowledge of the Code.

Other material issued by companies which relates to medicines but which is not intended as promotional material for those medicines per se, such as corporate advertising, press releases, market research material, financial information to inform shareholders, the Stock Exchange and the like, and written responses from medical information departments or similar to unsolicited enquiries from the public etc, should be examined to ensure that it does not contravene the Code or the relevant statutory requirements.

The examination of non-interventional studies is dealt with in Clause 25.2 and is not covered by Clause 14.

The names and qualifications of signatories and changes to them should be emailed to the Medicines and Healthcare Products Regulatory Agency signatories.advertising@mhra.gov.uk  and to the PMCPA 

Companies should note that the Medicines and Healthcare Products Regulatory Agency is entitled to request particulars of an advertisement, including particulars as to the content and form of the advertisement, the method of dissemination and the date of first dissemination, and such a request is not subject to any time limit. This does not apply to the certificates themselves in respect of which the three year limit in Clause 14.6 is applicable.